Articulating suturing device and method

• US 6,136,010 A
• Filed: 03/04/1999
• Issued: 10/24/2000
• Est. Priority Date: 03/04/1999
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Perclose Incorporated (Abbott Laboratories Incorporated)
• Inventors: Modesitt, D. Bruce, Zung, Michael, Isbell, Lewis, Andreas, Bernard H., Barrett, Michael
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): KING, ANTHONY S
• Application Number:
  US09/262,402
• Time in Patent Office: 600 Days
• Field of Search: 606/148, 606/139, 606/144, 606/145, 606/146, 606/149, 606/150
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft

Abstract

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

Claims

1. A method for suturing a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body, the method comprising:

attaching a flexible filament to a first fitting and a second fitting;

inserting a distal end of a probe through the puncture, said probe having a foot, said fitting being releasably mounted near a first end and a second end of the foot;

articulating the elongate foot of the probe within the blood vessel so that the foot moves from a low profile configuration aligned along a shaft of the probe to a deployed configuration extending laterally from the shaft and along the blood vessel, such that the fittings are positioned at opposed sides of the puncture;

forming a needle path by advancing a first needle through the vessel wall outside the puncture;

coupling the needle with the first fitting; and

withdrawing the first needle, the first fitting, and at least a first portion of the filament through the vessel wall along the needle path.

2. The method of claim 1, further comprising:

advancing a second needle through the vessel wall and into engagement with the second fitting.

3. The method of claim 2, further comprising withdrawing the second needle and the second fitting through the vessel wall, so that the withdrawing steps form a suture loop across the puncture.

4. The method of claim 3, wherein the withdrawing steps draw the suture from within the blood vessel out through the vessel wall.

5. The method of claim 2, wherein the first and second needle advancing steps comprise inserting the needles into the vessel so as to engage the fittings therein.

6. The method of claim 1, wherein the first fitting defines an opening and a latch, and further comprising attaching the fitting to the needle by latching the needle into the opening of the fitting.

7. The method of claim 6 wherein the needle has a recess and the fitting comprises a substantially cylindrical cuff having at least one tab extending therein, and wherein the advancing step deflects the at least one tab when the needle is received in the opening, the at least one tab resiliently flexing into the recess to secure the fitting to the needle.

8. The method of claim 6, further comprising directing a needle into the opening with a guide surface around the opening, the needle being flexible.

9. The method of claim 1, further comprising pulling the foot proximally against an interior surface of the vessel wall after the articulating step.

10. The method of claim 9 further comprising verifying that the foot is disposed within the vessel prior to the articulating step by monitoring a sensor adjacent the foot.

11. The method of claim 1, wherein the articulating step comprises sliding at least a portion of the foot axially along the shaft.

12. The method of claim 1, wherein the articulating step comprises pivoting the foot away from an axial orientation.

13. The method of claim 1, wherein the first needle withdraws said at least a portion of the flexible element without threading the flexible element into the needle.

14. A method for suturing an opening in a tissue, the method comprising:

inserting a distal end of a probe through the opening, the probe defining a probe axis;

articulating an elongate foot of the probe so that first and second ends of the foot extend laterally with the opening aligned therebetween;

supporting a suture by said first and second ends of the foot;

forming a first needle path from the probe through the tissue and to the first end of the foot;

forming a second needle path from the probe through the tissue and to the second end of the foot;

advancing said suture along the first and second needle paths to position a suture loop across the opening.

15. The method of claim 14, wherein the tissue comprises a blood vessel having an axis, wherein the articulating step is performed so that the articulated foot extends along the vessel axis within the vessel.

16. The method of claim 14, wherein the first and second needle path forming steps comprise deflecting first and second flexible needles at an angle relative to the probe axis and advancing the needles in cantilever radially outwardly from first and second fixed needle guides of the probe to the first and second ends of the articulated foot, the first and second ends of the articulated foot being separated laterally relative to the probe axis by a greater distance than the first and second needle guides.

17. The method of claim 14, wherein the articulating step comprises pulling a flexible element proximally so that the flexible element slides the foot proximally along the probe axis and so that the foot pivots laterally within the blood vessel.

18. The method of claim 14, further comprising inserting the foot through the puncture prior to the articulating step and pulling the shaft proximally after the articulating step so that the first and second ends of the deployed foot firmly engage the tissue beyond the puncture.

19. A method for suturing a blood vessel, the vessel having a vessel wall, the method comprising:

advancing a shaft toward the vessel wall, the shaft having an axis and a plurality of needle guides;

supporting a suture by two ends of said foot wherein said two ends extend laterally with the opening positioned therebetween;

deploying a foot adjacent the vessel wall so that the foot extends laterally from the shaft;

advancing a plurality of needles from needle guides of the shaft to the foot to form needle paths through the vessel wall, the needle guides deflecting the needles laterally so that a needle path width is greater than a cross-sectional dimension of the shaft; and

advancing said suture along the needle paths to position at least one suture loop across the puncture.

20. The method of claim 19, wherein the needles are flexible and the needle guides are fixed, and further comprising directing the needles laterally into secure engagement with fittings disposed releasably on the foot with a tapering needle receptacle surface of the foot.

21. A system for suturing a blood vessel, the vessel having a vessel wall, the system comprising;

a shaft suitable for insertion along the tissue tract and into the vessel through a puncture; and

a shaft suitable for insertion along the tissue tract and into the vessel through a puncture; and

a needle having a proximal end and a distal end suitable for forming a needle path through the vessel wall, the needle having a recessed engagement surface adjacent the distal end;

a flexible filament; and

a fitting releasably mounted on the foot and attached to the filament, the fitting having an opening and at least one tab extending into the opening, the tab securingly engaging the engagement surface when the needle advances through the vessel wall and into the opening so that the fitting and at least a portion of the filament can be withdrawn proximally along the needle path by the needle.

22. The system of claim 21, wherein the needles are flexible, and wherein the fitting is releasably supported within a receptacle surface oriented to laterally deflect the advancing needle toward the fitting.

23. The system of claim 22, further comprising a slot disposed along the receptacle surface, wherein the filament is releasably disposed in the slot, the slot configured to avoid engagement of the needle with the suture.

24. The system of claim 23, wherein the slot has a cross-section smaller than the needle.

25. The system of claim 22, wherein the receptacle surface tapers from a small cross-section adjacent the fitting to a large cross-section oriented toward the advancing needle.

26. The system of claim 21, wherein the at least one tab resiliently deflects into an indentation adjacent the engagement surface when the needle advances into the opening.

27. The system of claim 26, wherein the fitting comprises a tube having a proximal end and a distal end, the opening extending into the proximal end, the at least one tab formed of tube material by cutting slots through the tube, wherein the filament comprises suture extending distally from the distal end of the tube.

28. The system of claim 27, wherein the fitting further comprises a collar disposed about the suture, the collar crimped over an end of the suture.

29. The system of claim 21, wherein, the probe has a handle near a proximal end of the probe, actuation of the handle effecting articulation of the foot so that the fitting moves laterally from an axis of the probe.

30. A system for suturing a puncture of a blood vessel within a tissue tract, the vessel having a vessel wall and defining an axis, the system comprising:

a shaft having a proximal handle and a distal end suitable for insertion along the tissue tract and into the vessel through the puncture;

a foot mounted near the distal end of the shaft, the foot having a plurality of needle receptacles extendable laterally from the shaft;

a flexible filament extending between the needle receptacles of the foot;

a plurality of needles advanceable distally and laterally from the shaft, through the vessel wall outside the puncture, and to the needle receptacles of the foot.

31. The system of claim 30, further comprising a plurality of fittings disposed adjacent the receptacles of the foot, the fittings securingly engaging the needles so that the needles, fittings, and at least a portion of the filament can be withdrawn through the vessel wall along at least one of the needle paths formed by the needles without threading the filament into the needles.

32. The system of claim 30, wherein the foot comprises an elongate body defining an axis, the foot articulatable from a small profile configuration to a large profile configuration by actuating the proximal handle so that the foot slides axially and pivots laterally within the vessel.

33. A system for suturing a puncture of a blood vessel within a tissue tract, the vessel having a vessel wall, the system comprising:

a shaft having a proximal handle and a distal end suitable for insertion along the tissue tract and into the vessel through the puncture;

a foot mounted near the distal end of the shaft, the foot having a first needle receptacle and articulatable from a small profile configuration to a large profile configuration by actuation of the handle;

a first fitting removably mounted adjacent the first needle receptacle;

filament coupled to the first fitting; and

a first needle advanceable from the shaft to the first needle receptacle on the articulated foot, the first fitting securely engaging the first needle so that the secured first fitting and at least a portion of the filament can be withdrawn through the vessel wall by the first needle.

34. The system of claim 33, wherein the filament comprises a suture and couples the first fitting to a second fitting, and further comprising a second receptacle disposed near the distal end of the shaft and a second needle advanceable from the shaft to the receptacle to withdraw the second fitting proximally through the vessel wall and form a suture loop across the puncture.

35. The system of claim 33, further comprising a sensor near the distal end of the shaft to indicate when the shaft extends into the vessel, and wherein the deployed foot can engage an inner surface of the vessel wall when the shaft is withdrawn proximally to help axially position the shaft.

36. A probe for suturing an opening in a tissue, the probe comprising:

a shaft having a proximal end and a distal end and defining an axis therebetween, the shaft having a size and configuration suitable for insertion through the opening in the tissue;

an elongate foot movably mounted to the shaft;

an actuator extending along the shaft distally to the foot, movement of the actuator sliding the foot axially and pivoting the foot from a low profile configuration aligned along the shaft to a deployed configuration extending laterally from the shaft;

a suture supported by the foot; and

a needle advanceable from the shaft through the tissue and to the deployed foot.

37. The probe of claim 36, wherein the foot has a first end and a second end, and wherein a plurality of needles are extendable from the shaft to the ends of the foot.

38. The probe of claim 37, wherein a first length of suture extends between a first fitting at the first end of the probe to a second fitting at the second end of the probe, and wherein a second length of suture extends from a third fitting at the first end of the probe to a forth fitting at the second end of the probe, and wherein each fitting securingly engages an associated needle to draw ends of the first and second length of suture through the vessel wall and form a plurality of loops across the puncture.